基于CONSORT和STRICTA评价针刺治疗慢性阻塞性肺疾病随机对照试验质量的研究  

Quality Assessment of Randomized Controlled Trials on Acupuncture Treatment of Chronic Obstructive Pulmonary Disease based on CONSORT and STRICTA

作　　者：李茜 罗钦[1] 余欣 陈明 孙铭声 余曙光[1] 杨莎[1,4] Li Qian;Luo Qin;Yu Xin;Chen Ming;Sun Mingsheng;Yu Shuguang;Yang Sha(Acupuncture and Tuina School,Chengdu University of Traditional Chinese Medicine,Chengdu,610072,China;Panzhihua University,Panzhihua 617000,China;Clinical Research Center for Acupuncture and Moxibustion in Sichuan Province,Chengdu 610072,China;Acupuncture-Brain Science Research Center,Chengdu University of Traditional Chinese Medicine,Chengdu,610072,China)

机构地区：[1]成都中医药大学针灸推拿学院,四川成都610072 [2]攀枝花学院,四川攀枝花617000 [3]四川省针灸临床医学研究中心,四川成都610072 [4]成都中医药大学针灸脑科学研究中心,四川成都610072

出　　处：《成都中医药大学学报》2024年第3期74-80,共7页Journal of Chengdu University of Traditional Chinese Medicine

基　　金：国家中医药管理局中医药创新团队及人才支持计划项目(ZYYCXTD-D-202003)。

摘　　要：目的:采用Cochrane协作网RCT偏倚风险评价工具(RoB2)、临床试验报告统一标准(CONSORT)和针刺临床试验干预措施报告标准(STRICTA)评价针刺治疗慢性阻塞性肺疾病(Chronic Obstructive Pulmonary Disease,COPD)随机对照试验的质量,为提高临床证据质量提供参考。方法:计算机检索中国知网(CNKI)、维普中文期刊服务平台(VIP)、万方数据知识服务平台(WanFang)、中国生物医学文献数据库(CBM)以及PubMed、Cochrane Library、EmBase收录的关于针刺治疗COPD的随机对照试验,检索时限从建库开始到2022年2月28日。应用RoB2、CONSORT和STRICTA对纳入文献的方法学和报告质量进行评价,评价结果的一致性用kappa值表示。结果:最终纳入文献51篇,其中风险偏倚为“低风险”的3篇(5.9%),“不确定”的26篇(51.0%),“高风险”的22篇(43.1%)。根据CONSORT和STRICTA评价结果,报告率较高的条目有“研究目的和假设”“结局指标结果”“针刺穴位”等,报告率较低的条目有“随机”“盲法”“样本量的估算”“临床注册”以及“治疗师背景”“针刺细节”等。没有文献完全符合CONSORT声明和STRICTA清单。评价的一致性较好。结论:目前针刺治疗COPD随机对照试验的偏倚风险较高,报告质量整体较低,需要按照CONSORT和STRICTA进一步完善,以提高临床证据质量,使其更好的服务于临床。Objective:Evaluate the quality of randomized controlled trials on acupuncture for Chronic Obstructive Pulmonary Disease(COPD)based on Version 2 of the Cochrane tool for assessing risk of bias in randomized trial(RoB2),the consolidated standards of reporting Trials(CONSORT)and the standards for reporting interventions in clinical trials of acupuncture(STRICTA),in order to provide a reference for improving the quality of clinical evidence.Methods:CNKI,VIP,WanFang Data,CBM,PubMed,The Cochrane Library and EMbase databases were electronically searched to collect RCTs of acupuncture for COPD from inception to February 28,2022.Methodology and report quality of inclusions were evaluated using RoB2,CONSORT and STRITA.The consistency of evaluation results was represented by kappa value.Results:A total of 51 literatures were included,of which 3 were“low risk”(5.9%),26 were“some concern”(51.0%),and 22 were“high risk”(43.1%).According to the results of the CONSORT and STRICTA,the items with the higher reporting rates were“Specific objectives or hypotheses”,“outcomes”,“Names of points used”,etc.,while the items with lower reporting rates were“Random”,“Blinding”,“Sample Size Estimation”,“Clinical Registration”,“Background of acupuncturists”,“Acupuncture Details”,etc.There is no literature that fully complies with the CONSORT statement and the STRICTA list.The consistency of the evaluation results is satisfactory.Conclusion:At present,randomized controlled trials of acupuncture for COPD have a high risk of bias and overall low reporting quality,which needs to be further improved according to CONSORT and STRICTA to enhance the quality of clinical evidence and make it better serve clinical practice.

关 键 词：慢性阻塞性肺疾病 针刺 CONSORT标准 STRICTA标准 

分 类 号：R245[医药卫生—针灸推拿学] R256.1[医药卫生—中医临床基础]